Responsibility: 変更提案に対する薬事影響評価（変更カテゴリ―、必要なデータ）の特定 市販製品（低分子医薬品及び/又はバイオ医薬品）の変更管理における薬事的なリスク低減策を含むCMC薬事戦略の立案・実行支援 薬事アクション（一変・軽変・相談・照会回答）に供する高品質な資料の適時作成 海外関連部署に対する本邦規制要件の提示・解説 （担当マネージャー）チーム成果物（提案・資料等）の品質保証（整合性、適切性） Role: 製造所の変更提案に対し適時薬事影響評価を行う。 市販製品の薬事アクション（一変・軽変・相談・照会回答）に対し、提言、方針策定の支援、海外を含む関連部署との交渉を行う。 薬事アクション（一変・軽変・相談・照会回答）に供する資料につき、海外薬事を含む国内外の品質部門と協働して資料作成を行う。 他部署との協業上の問題（役割分担等）の解決・調整を支援し、プロセス改善に寄与する、あるいはその提言を行う。 （担当マネージャー） チームメンバーの上記活動に対する能力開発を含めた指導・支援を行う。 関連部署との個別の課題／問題につき、必要な調整・解決のための協議を行う。 ※職務内容および勤務地の変更範囲は会社の定めるところとする。 Basic Qualification スキル Skill 分析化学、製剤・薬剤学・プロセス工学（特に製造方法あるいはGMP）等に関する知識 品質に関わる国内規制、各種ガイドライン及び日本薬局方などの知識 ロジカルシンキング（論理的に物事を整理し、本質を見極められる） 他者との緊密な協力関係を構築し、協業できること Word、Excel、PowerPoint、Outlook、 経験 Experience CMC関連業務（分析、製造、QA、CMC薬事など、関連業務5年以上が望ましい） CMC薬事経験必須、スタッフは関連業務経験の有無により以下を考慮することがある - 変更管理業務を含むCMC薬事への興味の高さ・習得意志の強さ - 業務に利用可能な傑出したスキル（例：英語がnative levelなど）またはコンピテンシー（自己認知・成熟性、変革行動、顧客志向性など）を1つ以上有する 学位/資格/語学力 Education/certification/Language 医学、薬学、生物学、物理科学等での学士もしくはそれと同等以上
The Control Room and Disclosure of Interests (DOI) team of the Compliance, Conduct and Operational Risk (CCOR) organization is seeking a highly motivated individual for a role in our Tokyo office. The Control Room/DOI Team reviews research reports,
AWS Infrastructure Services owns the design, planning, delivery, and operation of all AWS global infrastructure. In other words, we’re the people who keep the cloud running. We support all AWS data centers and all of the
About Woven by ToyotaWoven by Toyota is enabling Toyota’s once-in-a-century transformation into a mobility company. Inspired by a legacy of innovating for the benefit of others, our mission is to challenge the current state of mobility
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
At Cadence, we hire and develop leaders and innovators who want to make an impact on the world of technology. Operations & Maintenance: . Oversee the daily operations of all building systems, including HVAC, electrical, plumbing,
Company Description It all started in sunny San Diego, California in 2004 when a visionary engineer, Fred Luddy, saw the potential to transform how we work. Fast forward to today — ServiceNow stands as a global
About Paidy Inc. Paidy is Japans pioneer and leading BNPL service company. At Paidy we believe in creating simple, instant experiences to take the hassle out of shopping with a touch of magic. Paidy offers instant,
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms
Company Introduction About Rocket Now Rocket Now is a food delivery service with no delivery or service fees. Consumers can enjoy a wide variety of cuisines, from Japanese and Western food to healthy options, as well
About Paidy Inc. Paidy is Japans pioneer and leading BNPL service company. At Paidy, we believe in creating simple, instant experiences to take the hassle out of shopping with a touch of magic. Paidy offers instant,
企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
REQUIREMENTS Required: • Culinary experience • Business-level English Preferred Qualifications: • Experience working as a Sous Chef (2+ years) POSTION SUMMARY Entry level management position that focuses on successfully accomplishing the daily objectives in the kitchen.
Compliance Operation Specialist Japan This role has been designed as ‘’Onsite’ with an expectation that you will primarily work from an HPE office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud company advancing the
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
WPP is the trusted growth partner for the world’s leading brands. We unite cutting-edge media intelligence and data solutions, world-class creativity, next-generation production, transformative enterprise solutions and expert strategic counsel in a single company – powered
General Information Job Advert Title: Indirect Tax Location: Nihonbashi, Tokyo Division: Corporate Controller Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We
Are you ready to make a meaningful impact and grow your career in payments? Join a team where your skills and ideas are valued, and you can build strong relationships with influential clients. You will be
Executive Summary of the Role: The Lead Solution Architect for the Insurance Claims area is a critical role responsible for overseeing the end-to-end design and execution of the Claims Modernization Program. This role ensures that the